Regulatory & Compliance

Biktarvy Gains FDA Approval for Broader HIV Treatment Use
Management & Regulatory Biktarvy Gains FDA Approval for Broader HIV Treatment Use

I'm thrilled to sit down with Ivan Kairatov, a renowned biopharma expert with extensive experience in research and development, as well as a deep understanding of technological innovation in the industry. Today, we’re diving into the recent FDA approval of Gilead Sciences’ Biktarvy for expanded HIV

FDA Approves Sephience for Rare PKU Disorder Treatment
Management & Regulatory FDA Approves Sephience for Rare PKU Disorder Treatment

Imagine living with a condition where even a small bite of protein-rich food could lead to severe neurological damage, a daily reality for thousands of individuals in the U.S. diagnosed with phenylketonuria (PKU), a rare genetic metabolic disorder. Affecting approximately one in every 13,500 to

FDA Fast-Tracks Breyanzi for Relapsed Marginal Zone Lymphoma
Research & Development FDA Fast-Tracks Breyanzi for Relapsed Marginal Zone Lymphoma

What happens when a rare cancer keeps coming back, defying every treatment thrown at it? For adults battling relapsed marginal zone lymphoma (MZL), a subtype of non-Hodgkin lymphoma, this relentless cycle has long been a harsh reality, but a flicker of hope emerges as Bristol Myers Squibb’s

How Does Alhemo Transform Haemophilia Treatment Options?
Management & Regulatory How Does Alhemo Transform Haemophilia Treatment Options?

Hemophilia, a rare inherited bleeding disorder impacting approximately 800,000 individuals globally, has long posed significant challenges for patients and healthcare providers due to the body's impaired ability to form blood clots. For many, the struggle to manage frequent bleeding episodes with

How Will FDA PreCheck Strengthen US Drug Supply Chains?
Management & Regulatory How Will FDA PreCheck Strengthen US Drug Supply Chains?

In a landscape where over 50% of pharmaceuticals distributed in the US are manufactured overseas, the fragility of the drug supply chain has become a pressing concern for national health security, prompting urgent action. Imagine a scenario where a global crisis disrupts access to essential

Keytruda Approved for Advanced Endometrial Cancer by NICE
Management & Regulatory Keytruda Approved for Advanced Endometrial Cancer by NICE

I'm thrilled to sit down with Ivan Kairatov, a renowned biopharma expert with extensive experience in research and development, as well as a deep understanding of technological innovation in the industry. Today, we’re diving into a groundbreaking advancement in cancer treatment: the recent

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